Diagnostic Tests for Fainting

((POST10) Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pacemaker, ICD, Hypertrophic cardiomyopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which test diagnoses fainting spells more quickly and accurately in older adults: a tilt table test or an implantable device that records heart activity. Participants will be randomly assigned to either undergo the Head Up Tilt Table (HUT) test or have an Implantable Loop Recorder inserted. The trial seeks individuals over 50 who have fainted at least once in the past year without a clear reason and have no serious health risks linked to their fainting. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance diagnostic methods for fainting spells.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these diagnostic tests are safe for patients with syncope?

Research has shown that both the implantable loop recorder and the head-up tilt table test safely diagnose fainting.

The implantable loop recorder, a tiny device placed under the skin, tracks heart rhythms. Studies have confirmed its safety, as it neither harms the heart nor alters the heart rate. It identifies heart rhythm problems without causing pain or discomfort.

The head-up tilt table test involves lying on a table that tilts to different angles to observe the body's reaction to position changes. Used for many years, this test is a trusted method for identifying the causes of fainting. It is generally well-tolerated, making it a safe option for patients.

Both methods have a strong safety record, making them reliable tools for diagnosing the causes of fainting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these diagnostic tests for fainting because they offer innovative ways to understand why someone might be experiencing episodes of fainting. The Implantable Loop Recorder is a small device placed under the skin to continuously monitor heart rhythms, which can detect irregularities that might occur infrequently and otherwise go unnoticed with traditional tests. The Head Up Tilt Table test, on the other hand, simulates conditions that can cause fainting and helps identify how the body responds to changes in position. These methods provide more detailed and continuous monitoring compared to standard tests, potentially leading to a more accurate diagnosis and better-targeted treatments.

What evidence suggests that this trial's treatments could be effective for diagnosing syncope?

In this trial, participants will be randomly assigned to one of two interventions: the Implantable Loop Recorder (ILR) or the Head Up Tilt Table (HUT) test. Research has shown that ILRs, such as the Reveal LINQ™, effectively capture and store crucial heart data. They are particularly useful for detecting serious heart rhythm issues, like slow heartbeats, in individuals with unexplained fainting and palpitations. Studies have found that these devices can continuously monitor heart activity for up to three years, assisting doctors in diagnosing heart-related causes of fainting.

In contrast, the HUT test is a traditional method used to investigate the causes of fainting. It helps determine whether fainting results from heart issues or other causes, such as epilepsy. The test involves observing the body's reaction to standing up after lying down. It is widely used to understand different types of fainting and can provide important insights into diagnosing the root cause of syncope. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people over 50 who've fainted at least once in the past year and don't know why, even after a check-up and heart tracing. They should be generally healthy enough to participate for a year. It's not for those with certain heart conditions, epilepsy, recent heart attacks, or existing pacemakers.

Inclusion Criteria

You are not at risk of dying from fainting.

I have fainted at least once in the last year.

My diagnosis is still unclear after basic tests.

Exclusion Criteria

You have been diagnosed with epilepsy using a test called electroencephalography.

You have a condition called bifascicular block.

I need a pacemaker or an ICD as recommended by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo either a Head-Up Tilt Table procedure or receive an Implantable Loop Recorder to diagnose the cause of syncope

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Device: Implantable Loop Recorder
• Diagnostic Test: Head Up Tilt Table (HUT)

Trial Overview The study compares two methods to diagnose unexplained fainting in older adults: a tilt table test that checks how your body responds to changes in position versus an implantable device that continuously records your heart's activity.

How Is the Trial Designed?

Group I: All eligible participants Experimental Treatment 2 Interventions

All eligible participants are randomly assigned to one of two interventions- early Head-Up Tilt Table procedure or early Implantable Loop Recorder. The assignment is random and at a 1:1 ratio between the two strategies. Interventions: Diagnostic Test: Head Up Tilt Table (HUT) Device: Implantable Loop Recorder

Device: Implantable Loop Recorder is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in United States as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in Canada as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Approved in Japan as ILR for:

• Unexplained syncope
• Arrhythmia
• Atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

The study involved 214 patients with recurrent unexplained syncope and compared three tilt testing protocols, finding that the GTN protocol led to significantly more diagnoses (47% overall diagnosis rate) than the other methods.

The GTN protocol demonstrated good sensitivity (50%) and high specificity (100%), while the drug-free protocol had lower sensitivity (21%), indicating that drug-augmented tilt testing is more effective for diagnosing syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised prospective comparison of three protocols for head-up tilt testing and carotid sinus massage. Farwell, DJ., Sulke, AN.[2009]

Tilt table tests are valuable for diagnosing neurally mediated syncope but have notable limitations that must be considered.

Implantable loop recorders have been shown to be safe and effective in diagnosing syncope, particularly in older patients, and can help identify those who may benefit from permanent pacing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tilt table testing and implantable loop recorders for syncope. Sheldon, R.[2012]

The Reveal implantable loop recorder (ILR) was effective in diagnosing the cause of unexplained recurrent syncope, providing a diagnosis in 78% of cases, primarily identifying cardiac issues.

In a study involving 570 patients over an average follow-up of 10 months, the ILR demonstrated a significant advantage over traditional diagnostic tests, supporting its early use in clinical practice for unexplained syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Edvardsson, N., Frykman, V., van Mechelen, R., et al.[2021]

In a study of 743 patients with implantable loop recorders (ILRs), those in secondary hospitals had a higher final diagnosis rate (55.4%) compared to those in tertiary hospitals (30.8%), despite similar clinical characteristics.

While tertiary hospitals conducted more electrophysiologic studies and tilt table tests, the safety profile was comparable between both groups, with no significant differences in rates of deaths or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the yield of the implantable loop recorder between secondary and tertiary centers. Lacunza-Ruiz, FJ., Moya-Mitjans, A., Martínez-Alday, J., et al.[2015]

In a study of 48 patients with unexplained syncope, the use of an implantable loop recorder (ILR) successfully identified arrhythmias in 88% of those who experienced recurrent syncope, demonstrating its effectiveness in diagnosing the underlying causes of syncope.

The findings from the ILR led to significant clinical interventions, including the implantation of 12 pacemakers and 2 radiofrequency ablations, highlighting its impact on treatment decisions for patients with unexplained syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic yield of the implantable loop recorder to detect the mechanism of syncope--a single center long term experience of a tertiary care center]. Brunckhorst, CB., Lemola, K., Holzmeister, J., et al.[2019]

The Reveal Plus insertable loop recorder (ILR) is effective for diagnosing cardiac arrhythmias in patients with unexplained fainting (syncope), providing a high diagnostic yield.

The device is easy to insert and has been associated with improved patient outcomes, highlighting the importance for medical-surgical nurses to understand its use and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the insertable loop recorder to detect cardiac arrhythmias during syncopal episodes. Reiff, PA., Gutierrez, JD.[2007]

In a study of 27 pediatric patients with infrequent syncope or palpitations, the Reveal insertable loop recorder (ILR) proved to be highly diagnostic, identifying issues in 95% of cases, primarily bradyarrhythmias like pauses and intermittent AV block.

The ILR was effective in guiding treatment decisions, leading to pacemaker implantation in five patients, while no life-threatening events were detected, highlighting its safety and utility in managing pediatric cardiac symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How revealing are insertable loop recorders in pediatrics? Frangini, PA., Cecchin, F., Jordao, L., et al.[2022]

The implantable loop recorder successfully diagnosed the cause of syncope in 60% of patients (15 out of 25) who had previously undergone extensive testing without a clear diagnosis.

During an average monitoring period of 13 months, the loop recorder detected significant arrhythmias in 40% of patients, including bradyarrhythmias and tachyarrhythmias, highlighting its efficacy in identifying underlying cardiac issues related to syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic benefit of the use of implanted loop recorder (Reveal Plus) for patients with syncope with unclear aetiology]. Mitro, P., Szakács, M., Bodnár, J., et al.[2014]

In a study of 547 patients with syncope at a Japanese medical center, the most common causes identified were cardiac syncope (34.0%) and reflex syncope (29.1%), highlighting the diverse origins of syncope in this population.

The use of implantable loop recorders (ILRs) significantly improved diagnostic rates for unexplained syncope, achieving 47% and 65% diagnostic rates at 1 and 2 years post-implantation, respectively, compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single center experience in Japanese patients with syncope. Onuki, T., Ito, H., Ochi, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5153047/

Head Up Tilt Testing: An Appraisal of Its Current Role in the ... Head up tilt testing (HTT) is now commonly used to investigate otherwise unexplained syncope and presyncope. This test has been used for over 20 years primarily ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0019483225000604

A contemporary review of the head-up tilt test: Utility and ... The Head-Up Tilt Test (HUTT) has been widely used for the past four decades as part of the overall assessment of the potential causes of collapse.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650575/

Yield of Tilt Table Test in Diagnosing Syncope in Patients ... The tilt table test (TTT) helps distinguish syncope from other common causes of complete loss of consciousness, such as epilepsy, define syncope subtypes and ...

4. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/17043-tilt-table-test

What a Tilt Table Test Can Show A tilt table test shows how your body responds to standing up after lying down. This test helps providers find the cause of your fainting.

5. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.95.4.951

Head-up Tilt Test | Circulation In the syncope group, seven patients (28%; 95% CI, 12% to 49%) had a positive tilt test, compared with eight in the control group (32%; 95% CI, 15% to 54%) (P= ...

6. mayoclinic.org mayoclinic.org/tests-procedures/tilt-table-test/about/pac-20395124

Tilt table test A tilt table test shows how the body reacts to changes in position. It can help find the cause of fainting or dizziness.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC80733/

The fainting patient: value of the head-upright tilt-table test in ... This test is frequently the gold standard for the evaluation of neurocardiogenic syncope, dysautonomia and postural orthostatic tachycardia syndrome.

8. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/tilt-table-testing

Tilt Table Testing A tilt table test is a test done to evaluate symptoms of syncope (fainting) by creating changes in posture and see how your heart and blood pressure ...